A strong commitment to sharing clinical trial results is important for medical progress

Novo Nordisk is committed to sharing information about all clinical studies and their results, irrespective if these are positive or negative. This is because important contributions to overall medical progress and general medical understanding are made by enabling access to trial information for researchers, participants in trials, and anyone else who may be interested.

Information about clinical trials is shared in several ways. At the beginning of a clinical trial, information is posted in relevant public registries. When the trial has ended, the goal is to publish the key conclusions in scientific journals. The results are communicated further by including them in applicable registries and on this website in the form of summaries in layperson language and clinical study reports. In addition, researchers can request access to detailed clinical trial data, which they can explore for their own research purposes. All information communicated and shared on clinical studies is anonymised.

See below for more details on how clinical trial data are shared.

Search published results of clinical trials

Novo Nordisk posts information about all clinical trials in publicly accessible clinical trial registries. Registries are an important source of information for researchers, medical doctors, and patients because they inform about ongoing and completed clinical trials. The trials are documented in national registries as required by local laws. However, not all national registries are publicly accessible and therefore, the clinical trials are also registered in the US registry ClinicalTrials.gov , which is open to the public. Novo Nordisk clinical trials results can also be found here. In addition, when clinical trials are carried out with at least one trial site in the European Economic Area, clinical trial applications for these clinical trials are submitted to the European Clinical Trials Database (EudraCT). The European Medicines Agency makes information from submissions related to phase 2-4 trials in adults and phase 1-4 trials in children publicly available via the EU Clinical Trials Register (EU CTR). All registrations are completed before the recruitment of trial participants starts and within the timeframes and formats that are specified by the individual registries. Non-interventional post-authorisation safety trials are registered in the publicly accessible European Union electronic Register of Post-Authorisation Studies (EU PAS Register). Novo Nordisk strives to provide consistent information across registries. Novo Nordisk also supports the WHO initiative of adding a unique identifier to clinical trials in order to track a specific trial across the various registries.

Results of clinical studies are presented at scientific conferences and published in medical journals, when possible

Regardless of clinical study outcomes, Novo Nordisk seeks publication of the key conclusions at scientific conferences and in peer-reviewed medical journals. Conference abstracts and scientific articles are submitted to relevant conferences and journal editors, who then decide whether or not to include the information. The submissions follow the guidelines provided by organizations such as GPP3, ICMJE, COPE, PhRMA, IFPMA, and others. Novo Nordisk strives to submit clinical study results that are of medical or scientific importance to scientific conferences and medical journals no later than 12-18 months after study completion.

Novo Nordisk publishes results from clinical studies in public registries

The results from Novo Nordisk’s clinical studies are communicated within the proper timeframes, in the formats and in the registries that are specified by current laws and regulations. For example, results from phase 2-4 clinical studies are submitted to the US register ‘ClinicalTrials.gov’. The results are then made publicly available in the appropriate format, and within the timelines specified in the FDA Amendments Act (FDAAA). Results are also submitted to the European Clinical Trials Database (EudraCT). Twelve months after a study’s completion, the European Medicines Agency publishes the results for phase 2-4 clinical studies in adults in the EU Clinical Trials Register. Results from phase 1-4 clinical studies in children are published 6 months after completion. In accordance with legislation, Novo Nordisk posts the entire study reports from non-interventional post-authorization safety studies in the publicly accessible European Union electronic Register of Post-Authorization Studies (EU PAS Register) within 14 days after the report of the results has been finalized.

Reports of clinical study results are published on the Novo Nordisk clinical trials website

The reports from all clinical studies that have been completed by Novo Nordisk after 1 January, 2006 are published here. The reports are posted within 30 days after the investigated medicine or medicine indication has been approved in both the United States and the European Union. The reports for clinical studies that have taken place after the US and EU approvals are published on the website 12 months after the study has been completed.

The results from discontinued projects are also published on the Novo Nordisk clinical trials website

In some cases, Novo Nordisk may decide to discontinue further investigations of a medicine or a specific medicine indication. If the development for market approval is not taken over by another party, the clinical study reports will be published 12 months after the public announcement of the study’s completion or discontinuation. Those results can be found here.

Scientific summaries of results (synopses) are published on the Novo Nordisk clinical trials website

Synopses for all Novo Nordisk studies are published on this website. The publication happens within 12 months after the investigated medicine has been approved in the first country.

Layperson summaries of clinical study results are published on the Novo Nordisk clinical trials website

Novo Nordisk publishes layperson summaries on this website from all Novo Nordisk clinical studies that have been completed on 1 January 2016 or later. Those summaries can be found here. The layperson summaries are posted within 30 days after the investigated medicine or medicine indication has been approved in both the United States and the European Union. The layperson summaries for clinical studies that have taken place after the US and EU approvals are published on the website 12 months after the study has been completed.

Researchers who wish to conduct independent analyses based on Novo Nordisk clinical study data can request access to the detailed datasets from Novo Nordisk-sponsored clinical studies that have been completed after 2001, provided that the explored medicine or medicinal indication has been approved in the US and EU. Novo Nordisk’s Independent Review Board evaluates received research proposals and grants access to scientifically robust requests on a quarterly basis. After approval by the Independent Review Board, the anonymised datasets are made available to the researchers within a closed IT system. More information about how to make a request is available here.

Novo Nordisk protects personal data

To ensure the trust and safety of participants in clinical studies, Novo Nordisk takes steps to protect participants’ personal data. Clinical study documents, such as clinical study reports, synopses, and protocols posted to public websites, are first ‘redacted’. Redaction is a process that ensures that any personal data and/or company confidential information is removed and that the published document is in compliance with regulatory guidance, data protection laws and company policies.

All the above happens in accordance with international and national laws and guidelines

• EU Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use

• EU Regulation (EC) No 1901/2006 of the European Parliament and of The Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/ EC, Directive 2001/83/EC and Regulation (EC) No 726/2004

This site contains information about clinical trials sponsored by Novo Nordisk. It is not intended to replace the advice of a healthcare professional and should not be construed as providing advice or making a recommendation. The information on this site should not be relied on as the basis for any decision or action. Only a physician can determine whether a specific product is correct for a particular patient. If you have question regarding any information contained on this site you should consult a physician.